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NBI-98854 once daily

Phase 1

Effect of Ketoconazole on the PK of NBI-98854 in Healthy Subjects | Small molecule | Other |Neurocrine Biosciences, Inc.|Last Updated: Sep 5, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01910480Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of NBI-98854 in Healthy SubjectsPHASE1 COMPLETED 24 — — Jul 1, 2013Aug 1, 2013Sep 5, 20131 United States
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Study Endpoints
Primary Endpoints
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 alone
45 minutes prior to NBI-98854 dosing, and at 15, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 48, 72 and 96 hours postdose
Evaluation of plasma concentrations of NBI-98854 and metabolites following administration of NBI-98854 concomitantly with ketoconazole
at 45 minutes prior to NBI-98854 dosing, and at 15, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 8, 12, 18, 24, 48, 72 and 96 hours postdose
Number of Participants with Adverse Events following dosing with NBI-98854
Up to 31 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
NBI-98854 followed by NBI-98854 with ketoconazoleEXPERIMENTAL50 mg NBI-98854 on Study Days 1 and 6 and 200 mg ketoconazole twice daily on Study Days 5 through 9.
Interventions
NameTypeDescription
NBI-98854 50 mg capsule once dailyDRUG -
Ketoconazole 400 mg (200 mg twice daily)DRUG -
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male or female volunteer, 18 to 40 years of age. * Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal birth control during the study. * Female subjects must not be pregnant, given birth within 1 year of study start, or breastfeedi...

Countries:United States
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